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BIRMINGHAM HIP◊

Resurfacing System

Product Information

The BIRMINGHAM HIP◊ Resurfacing (BHR◊) System is a conservative approach to hip arthroplasty in which an all-metal bearing couple is used to preserve, rather than replace, a patient’s femoral head and neck. It was first implanted in July 1997, and was approved for use in the United States by the Food and Drug Administration in 2006. Since its introduction, there have been over 175,000 BHR implantations worldwide.

Features of the BHR include:

Less bone resection than conventional total hip arthroplasty

Availability of global, long-term clinical outcomes data

Functionally optimized metallurgy and design

This successful, bone conserving hip resurfacing system is well documented through independent clinical and laboratory studies. Additional clinical evidence supporting the BHR is published by national and regional arthroplasty registries. This bone conserving procedure, combined with an implant design intended to decrease the risk of dislocation and excellent survivorship, makes the BHR ideal for the younger, active male patient. For additional information, contact your local sales representative or e-mail BHR.Inquiries@smith-nephew.com.

Clinical Evidence

The BHR◊ has over 19 years of clinical performance, and is the only hip resurfacing system with 14 years of published registry data behind it. When implanted in an appropriate patient, and in accordance with the surgical technique, the BHR offers a bone-conserving and clinically proven alternative to conventional total hip arthroplasty (THA) in male patients requiring a high level of post-operative function.

Clinical Studies

A list of the peer-reviewed publications reporting mid to long-term survivorship data for the BHR is provided in the table below. In summary, a total of 16,560 BHR implants are reported. Weighted average follow-up among these study populations is 7.1 years, with a weighted average survivorship estimate of 95.0 %.

Six of these studies report a total of 2,332 implants in 2,073 patients with a minimum of 10 years and a mean of 12.1 years of follow-up. In these long-term follow-up studies the weighted average survivorship is 94.4%.

Study Reference

Publication Year

Number of BHR Implants

Number of Patients

Mean Follow-up (Years)

Reported BHR % Survivorship

Daniel1

2014

1,000

886

13.7

95.8

Van Der Straeten2

2013

250

232

13.2

92.4

Treacy3

2011

144

130

10.8

93.5

Reito4

2014

261

219

10.4

91

Coulter5

2012

230

213

10.4

94.5

Matharu6

2013

447

393

10.1

94.1

Holland7

2012

100

90

9.6

92

Murray7

2012

646

554

8.0

87.1

McMinn8

2011

3,095

3,095

8.0

96

McMinn9

2008

110

103

7.8

95

Aulakh10

2010

101

95

7.5

97.7

Carrothers11

2010

5,000

NR

7.1

95.3

Madhu12

2011

117

101

7.0

91.5

Pollard13

2006

57

54

6.7

94

Revell14

2006

73

60

6.1

93.2

Pailhe15

2013

180

162

6.0

96.4

Khan16

2009

679

653

6.0

95.7

Heilpern17

2008

110

98

5.9

96.3

Nishii18

2007

50

45

5.6

96

Patel19

2014

109

85

5.2

95

Hing20

2007

230

212

5.0

99.1

McBryde21

2008

96

85

4.5

97

Steffen22

2008

610

532

4.2

95.1

Su23

2014

293

265

3.6

97.6

McBryde24

2010

2,123

1,826

3.5

97.5

Bisschop25

2013

149

129

3.4

87.5

Witzleb26

2008

300

263

2.0

98

Totals

16,560

Over 12,000

7.1

95.0

F/U >10 years

2,332

2,073

12.1

94.4

Arthroplasty Registries

Revision data for the BHR is reported by various national joint registries. The largest data sets are the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJREW).

The AOANJRR 2015 Annual Report27, tracking a total of 11,038 BHR devices, reported BHR survivorship of (95% confidence interval: 88.5 – 91.7) at 14 years follow-up, the longest of any resurfacing device.

*Detailed statistical analysis of the registry data for the BHR System from the NJREW, the AOANJRR and the Swedish Hip Register suggests that female patients, male patients aged 65 and older and patients requiring femoral head components 48mm in diameter and smaller are at greater risk of early revision than other patients. It was for this reason that Smith & Nephew undertook a field safety corrective action in June 2015, which (among other things) contraindicated the use of BHR in female patients and announced the withdrawal of femoral head components sized 46mm in diameter and smaller, and their corresponding acetabular cup sizes, from the market.

Design and Technology

The BHR◊ is intended for use in primary hip resurfacing arthroplasty and is comprised of a cemented As Cast CoCr femoral component and an uncemented As Cast CoCr HA coated acetabular component. The device is designed to be an alternative (more bone-conserving) option to conventional THA implants. The BHR is particularly suited to the younger, more active male patient requiring hip arthroplasty.

The BHR is intended for use only by surgeons who have received appropriate training and are familiar with the implant components, instruments, surgical technique (including with the importance of correct positioning), clinical applications, adverse events and associated risks.

The femoral and acetabular components (Figure 1 & Figure 2) are both composed of cast high-carbon-content cobalt chrome molybdenum (CoCrMo) alloy, which complies with ISO 5832: 2007 and is left in the ‘As-Cast’ condition. The external surface of the femoral head is predominantly spherical in form and is highly polished. The head is hollowed internally for seating onto the prepared native femoral head, to which it is fixed using acrylic bone cement. A distally protruding stem helps to achieve correct positioning of the head centrally along the axis of the femoral neck.

Figure 1. BHR Femoral Head

Figure 2. BHR Acetabular Cup

The As Cast cementless acetabular component is hemispherical in shape with a plasma-sprayed hydroxyapatite coating over a ‘cast-in’ CoCrMo beaded exterior surface, for bone ingrowth and osteointegration. Like the femoral component, the bearing surface of the acetabular cup component is predominantly spherical in form and is highly polished. Initial fixation of the acetabular cup (during the 12-week period required for osteointegration) is designed to be achieved using an interference-fit approach (with the native acetabulum under-reamed by 2mm).

The BHR System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring future ipsilateral hip joint revision.

Patients with severe osteopenia or patients with a family history of severe osteoporosis or severe osteopenia.

Patients with osteonecrosis or avascular necrosis (AVN) with >50% involvement of the femoral head (regardless of FICAT Grade).

Patients with multiple cysts of the femoral head (>1cm).

Note: In cases of questionable bone stock, a DEXA scan may be necessary to assess bone stock status.

Patients with known moderate to severe renal insufficiency

Patients who are immunosuppressed with diseases such as AIDS or persons receiving high doses of corticosteroids

Patients who are severely overweight

Patients with known or suspected metal sensitivity (e.g., jewelry)

WARNINGS AND PRECAUTIONS

Patients who, from plain radiograph pre-operative templating, appear to require 48mm femoral heads should not be considered as candidates for BHR implantation. Patients requiring a 48mm femoral head size are at a moderately elevated risk of requiring revision surgery earlier than expected. While Smith & Nephew concluded that the increased risk associated with this head size does not outweigh the potential benefit to the patient in the specific circumstance of intra-operative downsizing from a pre-operatively templated 50mm to a measurement of 48mm at the time of surgery, surgeons should use their best medical judgment to consider this information relative to the patient’s overall medical history and prognosis in determining its appropriateness as a surgical treatment.

Patients on medications (such as high-dose or chronic aminoglycoside treatment) or with co-morbidities (such as diabetes) that increase the risk of future, significant renal impairment should be advised of the possibility of increase in systemic metal ion concentration. Preoperative and postoperative monitoring of renal function (such creatinine, GFR, BUN) will be necessary for these patients.

Only physicians who have received appropriate training and are familiar with the implant components, instruments, procedure, clinical applications, adverse events, and risks associated with the BHR System should use this device. Contact Smith & Nephew Orthopaedics Ltd. for the surgical technique manual and procedural training protocol.

Based on literature reports together with the manufacturer’s post-market data, the following were identified as risk factors for early revision:

Patients who receive a 48mm femoral head;

Patients who receive a device which is incorrectly positioned;

Patients who have a diagnosis of avascular necrosis;

Patients who have congenital dysplasia; and

Patients who are obese

The more risk factors a patient has, the greater the risk of procedure failure requiring a revision of the hip.